CRANE SAFETY HYDROCORTISONE- hydrocortisone cream

Crane Safety Hydrocortisone by

Drug Labeling and Warnings

Crane Safety Hydrocortisone by is a Otc medication manufactured, distributed, or labeled by Crane Safety LLC, Unifirst First Aid Corporation. Drug facts, warnings, and ingredients follow.

Drug Details [pdf]

Drug Facts

Active ingredient (in each gram)

Hydrocortisone 1.0%

Purpose

Antipruritic (Anti-itch)

Uses

• for the temporary relief of itching associated with minor skin irritation, inflammation and rashes
• for externalgenital,femine and anal itching
• other uses for this product should be only under the advice and supervision of a doctor

Warnings

For external use only

Do not use

• for the teatment of diaper rash
• with any other hydrocortisone product unless you have consulted a doctor
• if you have vaginal discharge, consult a doctor

Stop use and ask a doctor if

• condition worsens, symptoms persist for more than 7 days or symptoms clear up and reappear again within a few days and do not begin use of any other hydrocortisone product
• rectal bleeding occurs

Keep out of reach of children.

If swallowed, get medical help or contact a Poison Control Center right away.

Directions

Adults and children 2 years of age and over:

apply to affected area not more than 3 to 4 times daily

Children under 2 years:

do not use and ask a doctor

For external genital itching in adults:

• when practical, clean affected area with mild soap and warm water and rinse thoroughly
• gently dry by patting or blotting with toilet tissue or a soft cloth before applying

Children under 12 years of age:

ask a doctor

Other information

• store at room temperature 59º to 86ºF (15º to 30ºC)
• tamper evident, do not use if packet is toen, cut or opened
• avoid excessive heat and humidity

Inactive ingredients

benzoic acid*, chlorphenesin*, citric acid*, emulsifying wax*, ethyl alcohol*, glycerin*, glycerol monostearate*, methylparaben, mineral oil, paraffin*, petrolatum, phenoxyethanol*, polysorbate 80*, propylparaben*, purified water, titanium dioxide*, trisodium citrate*, white wax*

May contain*

Questions or comments?

877.506.4291

Crane Safety Hydrocortisone 1% Cream Label

Hydrocortisone Cream 1%

Temporary Relief of Itching Associated With Minor Skin Irritation and Rashes

Product CS93373

0.9 g (1/32 oz) Packets

25/Box

CRANE Safety®

Crane Safety Hydrocortisone Label

Hydrocortisone Cream 1%

Temporary Relief of Itching Associated With Minor Skin Irritation and Rashes

Product CS93373

0.9 g (1/32 oz) Packets

25/Box

CRANE Safety®

INGREDIENTS AND APPEARANCE

CRANE SAFETY HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73408-933(NDC:47682-933)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
PROPYLPARABEN (UNII: Z8IX2SC1OH)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
ALCOHOL (UNII: 3K9958V90M)
METHYLPARABEN (UNII: A2I8C7HI9T)
PARAFFIN (UNII: I9O0E3H2ZE)
WHITE WAX (UNII: 7G1J5DA97F)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73408-933-73	25 in 1 BOX	01/17/2020
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/17/2020

CRANE SAFETY HYDROCORTISONE 
hydrocortisone cream

Product Information
Product Type	HUMAN OTC DRUG	Item Code (Source)	NDC: 73408-633(NDC:47682-633)
Route of Administration	TOPICAL

Active Ingredient/Active Moiety
Ingredient Name	Basis of Strength	Strength
HYDROCORTISONE (UNII: WI4X0X7BPJ) (HYDROCORTISONE - UNII:WI4X0X7BPJ)	HYDROCORTISONE	10 mg  in 1 g

Inactive Ingredients
Ingredient Name	Strength
METHYLPARABEN (UNII: A2I8C7HI9T)
MINERAL OIL (UNII: T5L8T28FGP)
PETROLATUM (UNII: 4T6H12BN9U)
WATER (UNII: 059QF0KO0R)
POLYSORBATE 80 (UNII: 6OZP39ZG8H)
TITANIUM DIOXIDE (UNII: 15FIX9V2JP)
PHENOXYETHANOL (UNII: HIE492ZZ3T)
CITRIC ACID MONOHYDRATE (UNII: 2968PHW8QP)
GLYCERYL MONOSTEARATE (UNII: 230OU9XXE4)
CHLORPHENESIN (UNII: I670DAL4SZ)
BENZOIC ACID (UNII: 8SKN0B0MIM)
GLYCERIN (UNII: PDC6A3C0OX)
TRISODIUM CITRATE DIHYDRATE (UNII: B22547B95K)

Packaging
#	Item Code	Package Description	Marketing Start Date	Marketing End Date
1	NDC: 73408-633-73	25 in 1 BOX	01/17/2020
1		0.9 g in 1 PACKET; Type 0: Not a Combination Product

Marketing Information
Marketing Category	Application Number or Monograph Citation	Marketing Start Date	Marketing End Date
OTC monograph not final	part348	01/17/2020

Labeler - Crane Safety LLC (080998015)

Registrant - Unifirst First Aid Corporation (832947092)

Establishment
Name	Address	ID/FEI	Business Operations
Medique Products		086911794	relabel(73408-933, 73408-633) , repack(73408-933, 73408-633)